PeNSAMI Phase 2: a multicenter Italian trial of home-based palliative care for people with severe multiple sclerosis and their carers

Conditions

Multiple Sclerosis (MS) Nervous System Diseases Multiple sclerosis

Rosato R, Pagano E, Giordano A, Farinotti M, Ponzio M, Veronese S, Confalonieri P, Grasso MG, Patti F, Solari A, PeNSAMI project.

2021-01-152 citations

10.1016/j.msard.2021.102756

Participant perspectives of a home-based palliative approach for people with severe multiple sclerosis: A qualitative study

Ambra Mara Giovannetti, Claudia Borreani, Elisabetta Bianchi, Andrea Giordano, Sabina Cilia et al. (22 authors)

PLoS ONE2018-07-1214 citations

10.1371/journal.pone.0200532

Individualized quality of life of severely affected multiple sclerosis patients: practicability and value in comparison with standard inventories.

Giovannetti AM, Pietrolongo E, Giordano A, Cimino V, Campanella A, Morone G, Fusco A, Lugaresi A, Confalonieri P, Patti F, Grasso MG, Ponzio M, Veronese S, Solari A.

2016-04-286 citations

10.1007/s11136-016-1303-9

Home-based palliative approach for people with severe multiple sclerosis and their carers: study protocol for a randomized controlled trial.

Solari A, Giordano A, Grasso MG, Confalonieri P, Patti F, Lugaresi A, Palmisano L, Amadeo R, Martino G, Ponzio M, Casale G, Borreani C, Causarano R, Veronese S, Zaratin P, Battaglia MA, PeNSAMI Project.

2015-04-2324 citations

10.1186/s13063-015-0695-0

Interventions

Study Intervention: At each center there will be a specially trained palliative care team (PCT) consisting of four professionals (physician, nurse, psychologist, and social worker). At

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects are eligible for recruitment if all of the following criteria are satisfied: 1. Definite MS (Polman 2011) 2. Age =18 years 3. Primary or secondary progressive MS course 4. EDSS = 8.0 5. Two or more unmet care needs from those identified in PeNSAMI Phase 1 (see above), or patient choice for comfort care only 6. One or more of the following patient clinical indicators (Thomas 2011): 6.1. Significant complex symptoms and medical complications 6.2. Dysphagia and poor nutritional status 6.3. Communication difficulties 6.4. Cognitive impairment, notably the onset of dementia 7. Presence of a carer (family member, relative, or friend, who is next of kin or is the key decision maker as designated by the [cognitively competent] patient and with whom the patient shares his/her life) 8. Signed informed consent (of both patient and carer)

Exclusion criteria

Exclusion criteria: 1. Hospitalized/institutionalized patients 2. Patients already receiving palliative care 3. Patient-carer dyads living out of the study area

Design outcomes

Primary

Measure	Time frame
Patient-related outcomes: 1. SEIQoL-DW - It was developed to assess quality of life from the individual's perspective (O'Boyle 1992). It is an interview-based instrument to assess the level of functioning in, and relative importance of, areas of life nominated by the respondent. The SEIQoL-DW index is obtained from the satisfaction and the weight of each elicited area, and can range from 0 (worst possible score) to 100 (best possible HRQoL score). 2. POS-S-MS - It comprises 18 items plus two open questions, using a 0-4 scale (Sleeman 2012). The psychometric properties of Core-POS (see below) and POS-S-MS have been assessed in patients severely affected by MS confirming that both are acceptable, reliable, and valid in this population (Sleeman 2012). An Italian version of POS-S-MS was devised for this study by the PeNSAMI lead centre. The score is the sum of the scores from each of the first 17 items, and therefore can range from 0 to 68.	—

Measure

Time frame

Patient-related outcomes: 1. SEIQoL-DW - It was developed to assess quality of life from the individual's perspective (O'Boyle 1992). It is an interview-based instrument to assess the level of functioning in, and relative importance of, areas of life nominated by the respondent. The SEIQoL-DW index is obtained from the satisfaction and the weight of each elicited area, and can range from 0 (worst possible score) to 100 (best possible HRQoL score). 2. POS-S-MS - It comprises 18 items plus two open questions, using a 0-4 scale (Sleeman 2012). The psychometric properties of Core-POS (see below) and POS-S-MS have been assessed in patients severely affected by MS confirming that both are acceptable, reliable, and valid in this population (Sleeman 2012). An Italian version of POS-S-MS was devised for this study by the PeNSAMI lead centre. The score is the sum of the scores from each of the first 17 items, and therefore can range from 0 to 68.

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Secondary

Measure	Time frame
Patient-related outcomes: 1. Core-POS - Self-assessed questionnaire on emotional, psychological and spiritual needs and provision of information and support [Hearn 1999; Higginson 2004]. It consists of 10 items, each scored from 0 (best) to 4 (worst). An additional question gives patients the opportunity to list their 'main problems'. The score is the sum of the scores from each of the 10 questions, and therefore can range from 0 to 40. 2. FIM - Care burden scale that consists of 13 physical (based on the Barthel Index) and 5 cognitive items [Hamilton 1987, Stineman 1997]. Each item is scored on the level of assistance required for an individual to perform activities of daily living from 1 (total dependence) to 7 (complete independence). The scale can be administered by a physician, nurse, therapist or lay person. Possible scores range from 18 to 126, with higher scores indicating more independence. 3. HADS - Self-assessed questionnaire consisting of 14 multiple choice (0-3 Likert scale) items probing symptoms of anxiety (7 items) and depression (7 items). HADS anxiety (HADS-A) and depression (HADS-D) scores range from 0 (no symptoms) to 21 (most severe symptoms) [Zigmond 1983]. Carer-related outcomes 1. SF-36 - Widely used self-reported generic measure of HRQoL consisting of 36 items in eight domains (physical function, social function, physical role limitations, emotional role limitations, pain, vitality, mental health, and general health) [Ware 1993, Apolone 1998]. Two composite scores (physical and mental) can be calculated. 2. HADS 3. EQ-5D - Most used generic preference-based measure of HRQoL which produces utility scores anchored at 0 (death) and 1 (perfect health) [Kind 1998; Johnson 1998]. EQ-5D utility scores represent preferences for particular health states. The descriptive system has five dimensions (mobility, self-care, usual activity, pain	—

Measure

Time frame

Patient-related outcomes: 1. Core-POS - Self-assessed questionnaire on emotional, psychological and spiritual needs and provision of information and support [Hearn 1999; Higginson 2004]. It consists of 10 items, each scored from 0 (best) to 4 (worst). An additional question gives patients the opportunity to list their 'main problems'. The score is the sum of the scores from each of the 10 questions, and therefore can range from 0 to 40. 2. FIM - Care burden scale that consists of 13 physical (based on the Barthel Index) and 5 cognitive items [Hamilton 1987, Stineman 1997]. Each item is scored on the level of assistance required for an individual to perform activities of daily living from 1 (total dependence) to 7 (complete independence). The scale can be administered by a physician, nurse, therapist or lay person. Possible scores range from 18 to 126, with higher scores indicating more independence. 3. HADS - Self-assessed questionnaire consisting of 14 multiple choice (0-3 Likert scale) items probing symptoms of anxiety (7 items) and depression (7 items). HADS anxiety (HADS-A) and depression (HADS-D) scores range from 0 (no symptoms) to 21 (most severe symptoms) [Zigmond 1983]. Carer-related outcomes 1. SF-36 - Widely used self-reported generic measure of HRQoL consisting of 36 items in eight domains (physical function, social function, physical role limitations, emotional role limitations, pain, vitality, mental health, and general health) [Ware 1993, Apolone 1998]. Two composite scores (physical and mental) can be calculated. 2. HADS 3. EQ-5D - Most used generic preference-based measure of HRQoL which produces utility scores anchored at 0 (death) and 1 (perfect health) [Kind 1998; Johnson 1998]. EQ-5D utility scores represent preferences for particular health states. The descriptive system has five dimensions (mobility, self-care, usual activity, pain

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Countries

Italy

Outcome results

None listed